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hearing and similar or improved outcomes compared with
tests performed with the SP on a softband. No major
pressure-related soft tissue complications were reported
and no implants were lost or removed, suggesting that the
device is efficacious and safe for the tested indication.
Magnetic bone conduction hearing implants have the
advantage over skin-penetrating systems of providing
improved cosmetics and eliminating the daily cleaning of
the site (25). With modern SP technology, it is possible to
obtain good sound transmission despite the soft tissue
attenuation that is inherent to magnetic bone conduction
hearing implants. Although the system must provide re-
liable retention of the SP to ensure good clinical outcomes,
it should not cause irritation of the skin or discomfort.
Threshold audiometry showed that the test device provides
significant functional gain at all frequencies. The improve-
ment is largest in the important speech frequency range up
to and including 3,000 Hz. Above 3,000 Hz, the perfor-
mance drops gradually as expected because of the soft tissue
attenuation, which is known to mainly affect the high fre-
quencies (26,27). It is anticipated that aided high-frequency
thresholds could be improved further (particularly by pre-
scribing more amplification in the high frequencies) by less
conservative SP settings than were used in the present in-
vestigation. It would be expected, however, that some at-
tenuation of sound through soft tissue will remain. In the
sentence tests in noise, which represents the most difficult
listening situation, significant improvement in SNR was
recorded compared with unaided hearing and compared
with softband tests. Speech recognition in quiet was sig-
nificantly better than for the unaided situation and similar
to softband. Although not statistically verified, a gradual
improvement in speech understanding was noted up to the
3-month visit, followed by relatively stable levels. A pos-
sible improvement in hearing performance may be explained
by adaptation as patients get used to the sound; it may also
be an effect of fine-tuning of the SP by the audiologist. The
fact that overall comparable outcomes were obtained with
FIG. 3.
A, Pure-tone thresholds per frequency for the unaided situation (preop), softband (preop), and test device (9 mo) in decibels. Error
bars represent standard error of the mean. N = 27. B, Speech perception in quiet for the unaided situation (preop), softband (preop), and test
device (4 wk, 6 wk, 3 mo, 9 mo). Percent correctly repeated words at 50, 65, and 80 dB SPL. Error bars represent standard error of the mean.
N = 27. C, Speech-to-noise ratio allowing 50% speech recognition for the unaided situation (preop), softband (preop), and test device (4 wk,
6 wk, 3 mo, 9 mo). N = 27. D, APHAB scores, change between unaided (preop) and test device (Visit 7). Positive values represent benefits
for the test device. AV indicates aversiveness; EC, ease of communication; RV, reverberation; BN, background noise; GLOBAL, global
score. Error bars represent standard error of the mean. N = 27.
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